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QA/RA professional - Medical Devices.-Tertiary qualifications (Molecular Virology, Analytical Chemistry, Biochemistry).-Management of medical device manufacturing, pharma and medical laboratories.-Management of quality operations in regulated ISO 13485, FDA 21 CFR 800/820, cGMP, TGA, NATA, NPAAC, ISO 15189 environments.-Project management.
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Director, Quality Assurance And Regulatory AffairsAtomo Diagnostics Oct 2019 - Apr 2023Sydney, Australia -
Manager, Quality Assurance And Regulatory AffairsAtomo Diagnostics Sep 2018 - Sep 2019 -
Senior Quality EngineerAtomo Diagnostics May 2018 - Aug 2018Sydney, AustraliaNew position commencing 30th April, 2018 -
Pathology Services ManagerClinical Genomics Aug 2015 - Feb 2018Sydney, AustraliaManagement of the day-to-day operations of the NATA-accredited pathology laboratory and the associated client services functions. -
Qc Immunochemistry ManagerCsl Limited Oct 2011 - Jul 2015Melbourne, AustraliaEmployed at the bioCSL (now Seqirus) Parkville site. Managed the day-to day operations and QC testing of several functional groups (Immunohaematology, Biochemistry, Immunology, Virology). Also managed QC Support functions - Sample Reception and LIMS administration. -
Manager/Director Of ManufacturingGti Diagnostics - Now Part Of Immucor Jul 2004 - Mar 2011Wisconsin, UsaManaged the day-to-day operations of departments responsible for manufacture of ELISA and Luminex bead immunoassays for the Transplantation, Blood Bank and Coagulation markets; from processing platelets and cell culture materials, protein purification, manufacture of kit components and packaging of finished kits. -
Production Process ScientistGti Diagnostics Apr 2003 - Jun 2004Wisconsin, UsaAudited processes to identify failure points and implemented process improvements to ensure consistency and adherence to cGMP, FDA 21 CFR 800/820 and ISO 13485 requirements. From Jan 2004, also managed the protein purification department. -
Senior Research Scientist/CoordinatorMedical College Of Wisconsin Sep 2002 - Apr 2003Wisconsin, UsaShort-term contract to assist the Director in setting up the new 'Center for Biopreparedness and Infectious Disease' (now Center for Infectious Disease Research). -
ScientistCross Cancer Institute - University Of Alberta Nov 1999 - Sep 2002Edmonton, Canada AreaEmployed on a temporary work visa in the Experimental Oncology research group. Studies involved the characterization of nucleoside transporters and defining their role in facilitating the transfer of anti-cancer drugs across cell membranes and in drug resistance. Project Manager of preclinical studies funded by pharma companies. Co-authored several publications.
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Project Co-OrdinatorCsiro Sep 1998 - Aug 1999Sydney, AustraliaEmployed on 12 month contract. Responsible for co-ordinating preclinical studies (drug delivery and gene therapy of prostate cancer) funded by a pharma company. -
Postdoc/Research ScientistJohnson & Johnson Jan 1994 - Aug 1998Sydney, AustraliaResearch projects involved the development of antisense/ribozyme therapeutics against HIV and cancer targets.
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Frequently Asked Questions about Marilyn Clarke
What is Marilyn Clarke's role at the current company?
Marilyn Clarke's current role is Retired.
What is Marilyn Clarke's email address?
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What schools did Marilyn Clarke attend?
Marilyn Clarke attended Macquarie University, The University Of Western Australia, The University Of James Cook.
What skills is Marilyn Clarke known for?
Marilyn Clarke has skills like Elisa, Cell Culture, Immunoassays, Gmp, Protein Purification, Process Improvement, Infectious Diseases, Clinical Development, Cancer, Leadership, Iso 13485, Biotechnology.
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2unisa.edu.au, adelaide.edu.au
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Marilyn Clarke
Clinical Director O&G Coffs Clinical Network, Academic Advisor ScuCoffs Harbour, Nsw -
marilyn clarke
Leisure & Lifestyle Activity Officer At Bushland Health Group LimitedNew South Wales, Australia
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